Enforcement Report - Week of June 20, 2012

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An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

An incident was reported that an operator's finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the tabletop with the thumb placed over its edge and fingers underneath

20 oz. product: Best Before Dates of 27 July 2012, 25 October 2012, 23 December 2012, 28 December 2012, and 28 March 2013; 2.5 lb. product: Best Before Dates of 04 December 2011, 26 February 2012, 17 March 2012, 14 June 2012, 11 August 2012, and 03 March 2013.

Class I

The product was found to contain undeclared milk, a known allergen, from a sub-ingredient in the powdered sunflower oil.

Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. These conditions range from back flow to free flow, which could result in over-infusion. Sigma's evaluation of subsequent complaints involving failed bearings indicated that the loss or degradation of bearing lubricant to be a more significant contributor to bearing failure than initially believed. Based upon the results of the analysis of these additional failures, Sigma determined that any bearings prior to the latest, improved design may be at risk for failure. Sigma decided to expand the recall of the Spectrum Infusion Pumps to include units manufactured from 1/18/2005 through 11/01/2010.

The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,

The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,

When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator
switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when
component supplier used a different supplier for a specific integrated circuit "IC" (switched from Philips to
Texas Instruments). On a specific control board, called PSM1 8 "CONTROL LOGIC BATTERY", the IC from
Texas Instruments is showing an unwanted behavior and is issuing an incorrect Peak Signal of 2.2Vmax.
This signal is enough to trigger the X-Ray exposure.

Part 0400-821-100, 0400-841-100 , 0400-851-100
0400-851-100S1, and 0400-851-100S2
all lots

Class II

The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

The clear tape, that is intended to aid in the prevention of patients fluids from contacting the surgeon/surgical staff through the sleeve seam of the toga, was not applied during the manufacturing process. Stryker has received 5 complaints associated with the defective seams which allowed bleed through of bodily fluids.

Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards.
The nonconformance documented below had the highest score for severity and probability using the risk analysis process:
- Calibration ring artifacts may be present on axial head scans that are performed with rotation times of 1.0 or 1.5 seconds.

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Chicken of the Sea is recalling Oysters supplied by Chicken of the Sea under the Chicken of the Sea, Pacific Pearl, and Ace of Diamonds brands because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Chicken of the Sea is recalling Oysters supplied by Chicken of the Sea under the Chicken of the Sea, Pacific Pearl, and Ace of Diamonds brands because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Chicken of the Sea is recalling Oysters supplied by Chicken of the Sea under the Chicken of the Sea, Pacific Pearl, and Ace of Diamonds brands because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

MW Polar is recalling Polar Whole Boiled Oysters from Korea because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Korean canned Medium Smoked Oysters, Napoleon brand, are recalled because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Korean canned Large Smoked Oysters, Napoleon brand, are recalled because the product has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.